PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00265034-1-L956,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L957,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L958,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L959,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L960,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L961,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L962,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L963,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L964,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L965,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L966,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L967,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L968,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L969,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L970,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L971,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L972,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L973,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L974,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L975,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L976,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L977,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L978,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L979,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L980,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L981,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L982,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L983,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L984,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L985,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L986,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L987,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L988,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L989,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L990,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L991,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L992,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L993,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L994,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L995,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L996,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L997,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L998,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L999,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1000,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1001,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1002,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1003,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1004,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1005,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1006,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1007,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1008,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1009,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1010,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1011,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1012,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1013,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1014,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1015,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1016,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1017,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1018,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1019,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1020,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1021,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1022,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1023,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1024,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1025,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1026,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1027,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1028,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1029,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1030,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1031,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1032,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1033,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1034,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1035,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1036,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1037,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1038,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1039,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1040,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1041,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1042,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1043,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1044,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1045,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1046,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1047,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1048,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1049,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1050,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1051,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1052,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1053,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1054,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1055,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1056,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1057,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1058,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1059,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1060,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1061,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1062,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1063,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1064,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1065,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1066,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1067,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1068,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1069,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1070,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to malposition/malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1071,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1072,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1073,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1074,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1075,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1076,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1077,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1078,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1079,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1080,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1081,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1082,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1083,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1084,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1085,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1086,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1087,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1088,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1089,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1090,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1091,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1092,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1093,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1094,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1095,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1096,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1097,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1098,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1099,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1100,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1101,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1102,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1103,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1104,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1105,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1106,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1107,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1108,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1109,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1110,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1111,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1112,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1113,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1114,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1115,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1116,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1117,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1118,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1119,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1120,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1121,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1122,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1123,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1124,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1125,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1126,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1127,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1128,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1129,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1130,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1131,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1132,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1133,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1134,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1135,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1136,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1137,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1138,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1139,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1140,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1141,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1142,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1143,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1144,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1145,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1146,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1147,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1148,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1149,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1150,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1151,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1152,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1153,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1154,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1155,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1156,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1157,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1158,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265034-1-L1159,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA between 01-Feb-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, one thousand one hundred and fifty-nine (1,159) hips required revision due to the following reasons: two hundred eighty-six (286) hips due to infection, one hundred forty-four (144) hips due to dislocation/instability, one hundred twenty-six (126) hips due to fracture, twenty-six (26) hips due to malposition/malalignment, one hundred thirteen (113) hips due to aseptic loosening, twenty-six (26) hips due to wear, and four hundred thirty-eight (438) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-one thousand two hundred and seventy-seven (31,277) hips underwent primary THA in which an R3 Acetabular Shell was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.1% (2.9%-3.3%) vs 2.7% (2.7%-2.8%) of the class.;-At 2nd postoperative year: 3.4% (3.2%-3.6%) vs 3.1% (3.1%-3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.5%-3.9%) vs 3.4% (3.3%-3.4%) of the class.;-At 4th postoperative year: 3.9% (3.6%-4.1%) vs 3.6% (3.5%-3.6%) of the class.;-At 5th postoperative year: 4.0% (3.8%-4.2%) vs 3.8% (3.7%-3.8%) of the class.;-At 7th postoperative year: 4.3% (4.0%-4.6%) vs 4.1% (4.1%-4.2%) of the class.;-At 9th postoperative year: 4.6% (4.3%-5.0%) vs 4.6% (4.5%-4.6%) of the class.;-At 10th postoperative year: 4.8% (4.3%-5.2%) vs 4.8% (4.7%-4.9%) of the class.;In analysis of reasons for revision of R3 Acetabular Shell, infection (24.7%) [286/1,159] and other/unknown causes (37.7%) [438/1,159] account for over a combined 62% of reasons for revision. Both infection and other/unknown causes are not necessarily related to the R3 implant and may not reflect the performance of the device. The present analysis is in alignment with what was previously reported for the R3 Acetabular System.;By observing the cumulative revision rates above, it can be determined that statistically significant differences between the study device and the THR class are present only at the 1st and 3rd postoperative years, where the study device demonstrates higher revision rates than the class, as indicated by non overlapping 95% confidence intervals. For all other evaluated postoperative periods, the 95% confidence intervals overlap, indicating no statistically significant difference between the revision rates of the study device and the THR class at those time points. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L81,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L82,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L83,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L84,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L85,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to dislocation /instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L86,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to peri-prosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L87,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L88,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L89,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L90,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L91,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00265035-1-L92,,7/16/2026,4/1/2026,R3 Acetabular System,R3 Acetabular Shell,,,,,,K211176,,IN,"It was reported that, based on data from Endoprothesenregister Joint Registry (EPRD) in Germany, a total of seven hundred and six (706) hips underwent revision THA procedures between 01-Jul-2013 and 31-Mar-2025, using R3 Acetabular Shell. From these, one (1) hip required re-revision surgery due to other/unknown.","Reporting Quarter: 2 (April 1 - June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the Endoprothesenregister (EPRD) from Germany, a total of seven hundred and six (706) hips underwent revision THA between 01-Jul-2013 and 31-Mar-2025 in which a R3 Acetabular Shell was implanted. Of these, ninety-two (92) hips required re-revision due to the following reasons: twenty seven (27) hips due to infection, fourteen (14) hips due to dislocation/instability, three (3) hips due to fracture, nineteen (19) hips due to aseptic loosening, seven (7) hips due to wear, and twenty two (22) hips due to other/unknown reasons.;Timeframe of Registry Data: Implantations conducted between 01-Jul-2013 and 31-Mar-2025 in Germany;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of seven hundred and six (706) hips underwent revision THA in which a R3 Acetabular Shell was implanted in Germany between 01-Jul-2013 and 31-Mar-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 9.9% (7.6%-12.1%) vs 11.8% (11.6%-12.1%) of the class;-At 2nd postoperative year: 11.4% (9.0%-13.8%) vs 13.8% (13.5%-14.1%) of the class;-At 3rd postoperative year: 12.8% (10.2%-15.4%) vs 15.0% (14.8%-15.3%) of the class;-At 4th postoperative year: 13.8% (11.1%-16.5%) vs 16.0% (15.8%-16.3%) of the class;-At 5th postoperative year: 14.2% (11.3%-16.9%) vs 16.8% (16.5%-17.1%) of the class;-At 7th postoperative year: 15.1% (11.7%-18.4%) vs 18.4% (18.0%-18.7%) of the class;-At 9th postoperative year: 18.3% (12.7%-23.6%) vs 19.7% (19.3%-20.1%) of the class;-At 10th postoperative year: 18.3% (12.7%-23.6%) vs 20.4% (19.9%-20.9%) of the class;By observing the cumulative re revision rates above, it can be determined that there is no statistically significant difference between the re revision rates of the study device and the revision THR class at any postoperative time point evaluated, as determined by overlapping 95% confidence intervals. Although the point estimates for the study device are consistently lower than those of the revision THR class across all years, the overlap of the confidence intervals indicates that these differences are not statistically significant.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L565,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L566,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L567,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L568,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L569,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L570,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L571,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L572,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L573,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L574,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L575,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L576,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L577,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L578,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L579,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L580,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L581,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L582,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L583,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L584,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L585,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L586,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L587,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L588,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L589,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L590,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L591,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L592,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L593,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L594,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L595,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L596,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L597,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L598,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L599,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L600,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L601,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L602,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L603,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L604,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L605,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L606,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L607,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L608,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L609,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L610,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L611,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L612,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L613,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L614,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L615,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L616,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L617,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L618,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L619,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L620,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L621,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L622,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L623,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to malposition/malalignment","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L624,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L625,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L626,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L627,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L628,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L629,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L630,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L631,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L632,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L633,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L634,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L635,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L636,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L637,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L638,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L639,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L640,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L641,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L642,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L643,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L644,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L645,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L646,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L647,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L648,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L649,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L650,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L651,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L652,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L653,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L654,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L655,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L656,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L657,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L658,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L659,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L660,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L661,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L662,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L663,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L664,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L665,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L666,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L667,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L668,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L669,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266160-1-L670,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accesory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedures between 01-Feb-2013 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, six hundred and seventy (670) hips were later revised due to the following reasons: seventy eight (78) hips due to dislocation/instability, one hundred and eighty two (182) hips due to infection, sixty four (64) hips due to periprosthetic fracture, sixteen (16) hips due to malposition/malalignment, sixty three (63) hips due to aseptic loosening, twenty six (26) hips due to wear, two hundred forty one (241) due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;Timeframe of Registry Data: Implantations conducted between 01-Feb-2013 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eighteen thousand six hundred ninety three (18,693) hips underwent primary THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Feb-2013 and 31-Mar-2025. ;These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and THA for PF-fracture. The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (R3 Accessory Acetabular components used in 14,559 hips vs 507,950 procedures listed for the class).;-At 1st postoperative year: 2.9% (2.7%¿3.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 3.3% (3.0%¿3.6%) vs 3.1% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 3.6% (3.2%¿3.9%) vs 3.4% (3.3%¿3.4%) of the class.;-At 4th postoperative year: 3.6% (3.3%¿4.0%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 3.8% (3.5%¿4.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 4.0% (3.7%¿4.4%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 4.3% (3.9%¿4.8%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 4.7% (3.8%¿5.6%) vs 4.8% (4.7%¿4.9%) of the class.;2. Elective THA with Cemented Stems (R3 Accessory Acetabular components used in 3,312 hips vs 139,151 procedures listed for the class).;-At 1st postoperative year: 2.7% (2.1%¿3.3%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 3.0% (2.4%¿3.6%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 3.2% (2.6%¿3.8%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 3.4% (2.7%¿4.0%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 3.4% (2.7%¿4.0%) vs 3.5% (3.4%¿3.6%) of the class.;-At 7th postoperative year: 3.4% (2.8%¿4.1%) vs 3.9% (3.8%¿4.1%) of the class.;-At 9th postoperative year: 3.4% (2.8%¿4.1%) vs 4.4% (4.2%¿4.5%) of the class.;-At 10th postoperative year: 3.4% (2.8%¿4.1%) vs 4.6% (4.4%¿4.8%) of the class.;3. THA for PF-fracture (R3 Accessory Acetabular components used in 821 hips vs 42,229 procedures listed for the class).;-At 1st postoperative year: 6.1% (4.4%¿7.7%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 6.4% (4.7%¿8.2%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 6.9% (5.1%¿8.8%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 6.9% (5.1%¿8.8%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 6.9% (5.1%¿8.8%) vs 7.7% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.7% (5.3%¿10.0%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.7% (5.3%¿10.0%) vs 8.8% (8.3%¿9.2%) of the class.;;The three most frequent causes of revision were: other-unknown reasons (35.9%) and infections (27.2%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L61,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L62,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L63,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L64,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L65,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L66,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L67,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to infection","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L68,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L69,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to dislocation/instability","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L70,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to periprosthetic fracture","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L71,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L72,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L73,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to aseptic loosening","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L74,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L75,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00266161-1-L76,,7/16/2026,4/1/2026,R3 Acetabular System ,R3 Accessory Acetabular Components (R3/Reflection Hole Cover),,,,,,K070756,,IN,"It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, one (1) hip was later re-revised due to other/unknown reasons","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister (EPRD) from Germany, a total of four hundred ninety four (494) hips underwent Revision THA procedures between 01-Nov-2014 and 31-Mar-2025, using R3 Accessory Acetabular Components. From these, seventy six (76) hips were later re-revised due to the following reasons: twenty-five (25) hips due to infection, fourteen (14) hips due to dislocation/instability, two (2) hips due to periprosthetic fracture, fifteen (15) hips due to aseptic loosening, five (5) hips due to wear, fifteen (15) hips due to other/unknown reasons.;Registry data included in this report may overlap, as implant components can be used together within the same reconstruction system and may therefore be reported in more than one registry dataset. Due to the stratified and aggregated nature of the data, Smith+Nephew is unable to identify or exclude potential duplication. Therefore, all data is reported as provided for each implant component. ;;Timeframe of Registry Data: Implantations conducted between 01-Nov-2014 and 31-Mar-2025 in Germany;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of four hundred ninety?four (494) hips underwent Revision THA procedure in which a R3 Accessory Acetabular Component was implanted in Germany between 01-Nov-2014 and 31-Mar-2025. ;;The R3 Accessory Acetabular components are performing in line with the respective class subcategory at the available follow-up time (1-10 years) based on overlapping of confidence intervals. The following cumulative re-revision rates with 95% confidence intervals for each subcategory are presented in this report:;-At 1st postoperative year: 11.6% (8.7%¿14.5%) vs 12.0% (11.8%¿12.3%) of the class.;-At 2nd postoperative year: 13.1% (10.0%¿16.1%) vs 14.0% (13.8%¿14.3%) of the class.;-At 3rd postoperative year: 15.2% (11.9%¿18.5%) vs 15.2% (15.0%¿15.5%) of the class.;-At 4th postoperative year: 16.3% (12.7%¿19.7%) vs 16.3% (16.0%¿16.5%) of the class.;-At 5th postoperative year: 16.7% (13.1%¿20.2%) vs 17.1% (16.8%¿17.4%) of the class.;-At 7th postoperative year: 18.3% (13.5%¿22.8%) vs 18.6% (18.2%¿18.9%) of the class.;-At 9th postoperative year: 21.3% (13.6%¿28.3%) vs 19.9% (19.5%¿20.3%) of the class.;-At 10th postoperative year: 21.3% (13.6%¿28.3%) vs 20.6% (20.1%¿21.1%) of the class.;;The three most frequent causes of re-revision were: infections (32.9%), other-unknown reasons (19.8%), and aseptic loosening (19.7%). Revision due to infection is most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Additionally, this combination of R3 Accessory Acetabular components accounted for 494 implantations out of the 80,991 other total hip arthroplasty products. Therefore, the low number of implants at risk make the statistical model not reliable for comparison to class average, as shown by wider confidence intervals.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279930-1-L32,,7/16/2026,5/19/2026,REFLECTION Acetabular System,REFLECTION Acetabular Component ,,,,,,K960094,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of one thousand two hundred thirty-six (1,236) hips underwent primary THA procedures between 01-Feb-2013 and 31-Jan-2024, using REFECTION Acetabular Component. From these, one (1) patient required a revision surgery duo to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of one thousand two hundred thirty-six (1,236) hips underwent primary THA procedures between 01-Feb-2013 and 31-Jan-2024, using REFECTION Acetabular Component. From these, thirty-four (34) hips were later revised due to the following complications: six (6) hips due to infection, two (2) hips due to periprosthetic fracture, four (4) hips due to dislocation/instability, four (4) hips due to aseptic loosening, one (1) hip due to wear and seventeen (17) hips due to other-unknown reasons. ;Timeframe of Registry data: Implantations conducted between 01-Feb-2013 and 31-Jan-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of one thousand two hundred thirty-six (1,236) primary THA procedures with REFECTION Acetabular Components have been performed in Germany between 01-Feb-2013 and 31-Jan-2024. These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and Non-Elective THA after bone fracture(s). The REFECTION Acetabular Component is performing in line across all categories and timepoints with the respective class subcategory at the available follow-up time. The revision rate for REFLECTION Acetabular Component was either statistically significantly lower, or not statistically significantly different that all other THAs. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (REFECTION Acetabular Component used in 1191 hips vs 521,318 procedures listed for the class).;-At 1st postoperative year: 1.5% (0.8%¿2.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 1.9% (1.2%¿2.7%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 2.2% (1.4%¿3.0%) vs 3.4% (3.4%¿3.5%) of the class.;-At 4th postoperative year: 2.3% (1.4%¿3.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 2.3% (1.4%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 2.8% (1.8%¿3.8%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 3.0% (1.9%¿4.2%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 3.0% (1.9%¿4.2%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (REFECTION Acetabular Component used in 16 hips vs 142,447 procedures listed for the class).;-At 1st postoperative year: 6.2% (0.0%¿17.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 6.2% (0.0%¿17.4%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 6.2% (0.0%¿17.4%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 6.2% (0.0%¿17.4%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 6.2% (0.0%¿17.4%) vs 3.5% (3.3%¿3.6%) of the class.;-At 7th postoperative year: 6.2% (0.0%¿17.4%) vs 3.9% (3.8%¿4.0%) of the class.;;3.Non-Elective THA after bone fracture(s) (REFECTION Acetabular Component used in 29 hips vs 43,021 procedures listed for the class).;-At 1st postoperative year: 3.4% (0.0%¿9.9%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 7.3% (0.0%¿16.6%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 7.3% (0.0%¿16.6%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 7.3% (0.0%¿16.6%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 7.3% (0.0%¿16.6%) vs 7.6% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.3% (0.0%¿16.6%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.3% (0.0%¿16.6%) vs 8.8% (8.3%¿9.2%) of the class.;;The two most frequent causes of revision were: infections (17.6%) and other/unknown (50%). Revision due to infection are most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Wide confidence intervals associated with REFLECTION implants may be affected by the relatively low number of implantations.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279930-1-L33,,7/16/2026,5/19/2026,REFLECTION Acetabular System,REFLECTION Acetabular Component ,,,,,,K960094,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of one thousand two hundred thirty-six (1,236) hips underwent primary THA procedures between 01-Feb-2013 and 31-Jan-2024, using REFECTION Acetabular Component. From these, one (1) patient required a revision surgery duo to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of one thousand two hundred thirty-six (1,236) hips underwent primary THA procedures between 01-Feb-2013 and 31-Jan-2024, using REFECTION Acetabular Component. From these, thirty-four (34) hips were later revised due to the following complications: six (6) hips due to infection, two (2) hips due to periprosthetic fracture, four (4) hips due to dislocation/instability, four (4) hips due to aseptic loosening, one (1) hip due to wear and seventeen (17) hips due to other-unknown reasons. ;Timeframe of Registry data: Implantations conducted between 01-Feb-2013 and 31-Jan-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of one thousand two hundred thirty-six (1,236) primary THA procedures with REFECTION Acetabular Components have been performed in Germany between 01-Feb-2013 and 31-Jan-2024. These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and Non-Elective THA after bone fracture(s). The REFECTION Acetabular Component is performing in line across all categories and timepoints with the respective class subcategory at the available follow-up time. The revision rate for REFLECTION Acetabular Component was either statistically significantly lower, or not statistically significantly different that all other THAs. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (REFECTION Acetabular Component used in 1191 hips vs 521,318 procedures listed for the class).;-At 1st postoperative year: 1.5% (0.8%¿2.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 1.9% (1.2%¿2.7%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 2.2% (1.4%¿3.0%) vs 3.4% (3.4%¿3.5%) of the class.;-At 4th postoperative year: 2.3% (1.4%¿3.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 2.3% (1.4%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 2.8% (1.8%¿3.8%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 3.0% (1.9%¿4.2%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 3.0% (1.9%¿4.2%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (REFECTION Acetabular Component used in 16 hips vs 142,447 procedures listed for the class).;-At 1st postoperative year: 6.2% (0.0%¿17.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 6.2% (0.0%¿17.4%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 6.2% (0.0%¿17.4%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 6.2% (0.0%¿17.4%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 6.2% (0.0%¿17.4%) vs 3.5% (3.3%¿3.6%) of the class.;-At 7th postoperative year: 6.2% (0.0%¿17.4%) vs 3.9% (3.8%¿4.0%) of the class.;;3.Non-Elective THA after bone fracture(s) (REFECTION Acetabular Component used in 29 hips vs 43,021 procedures listed for the class).;-At 1st postoperative year: 3.4% (0.0%¿9.9%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 7.3% (0.0%¿16.6%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 7.3% (0.0%¿16.6%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 7.3% (0.0%¿16.6%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 7.3% (0.0%¿16.6%) vs 7.6% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.3% (0.0%¿16.6%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.3% (0.0%¿16.6%) vs 8.8% (8.3%¿9.2%) of the class.;;The two most frequent causes of revision were: infections (17.6%) and other/unknown (50%). Revision due to infection are most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Wide confidence intervals associated with REFLECTION implants may be affected by the relatively low number of implantations.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279930-1-L34,,7/16/2026,5/19/2026,REFLECTION Acetabular System,REFLECTION Acetabular Component ,,,,,,K960094,,IN,"It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of one thousand two hundred thirty-six (1,236) hips underwent primary THA procedures between 01-Feb-2013 and 31-Jan-2024, using REFECTION Acetabular Component. From these, one (1) patient required a revision surgery duo to other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Endoprothesenregister Joint Registry (EPRD) from Germany, a total of one thousand two hundred thirty-six (1,236) hips underwent primary THA procedures between 01-Feb-2013 and 31-Jan-2024, using REFECTION Acetabular Component. From these, thirty-four (34) hips were later revised due to the following complications: six (6) hips due to infection, two (2) hips due to periprosthetic fracture, four (4) hips due to dislocation/instability, four (4) hips due to aseptic loosening, one (1) hip due to wear and seventeen (17) hips due to other-unknown reasons. ;Timeframe of Registry data: Implantations conducted between 01-Feb-2013 and 31-Jan-2024 in Germany.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of one thousand two hundred thirty-six (1,236) primary THA procedures with REFECTION Acetabular Components have been performed in Germany between 01-Feb-2013 and 31-Jan-2024. These components have been paired and reviewed based on the following subcategories: Elective THA with cementless stems, Elective THA with cemented stems and Non-Elective THA after bone fracture(s). The REFECTION Acetabular Component is performing in line across all categories and timepoints with the respective class subcategory at the available follow-up time. The revision rate for REFLECTION Acetabular Component was either statistically significantly lower, or not statistically significantly different that all other THAs. The following cumulative revision rates with 95% confidence intervals for each subcategory are presented in this report:;1. Elective THA with Cementless Stems (REFECTION Acetabular Component used in 1191 hips vs 521,318 procedures listed for the class).;-At 1st postoperative year: 1.5% (0.8%¿2.2%) vs 2.8% (2.7%¿2.8%) of the class.;-At 2nd postoperative year: 1.9% (1.2%¿2.7%) vs 3.2% (3.1%¿3.2%) of the class.;-At 3rd postoperative year: 2.2% (1.4%¿3.0%) vs 3.4% (3.4%¿3.5%) of the class.;-At 4th postoperative year: 2.3% (1.4%¿3.2%) vs 3.6% (3.5%¿3.6%) of the class.;-At 5th postoperative year: 2.3% (1.4%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;-At 7th postoperative year: 2.8% (1.8%¿3.8%) vs 4.2% (4.1%¿4.2%) of the class.;-At 9th postoperative year: 3.0% (1.9%¿4.2%) vs 4.6% (4.5%¿4.6%) of the class.;-At 10th postoperative year: 3.0% (1.9%¿4.2%) vs 4.8% (4.7%¿4.9%) of the class.;;2. Elective THA with Cemented Stems (REFECTION Acetabular Component used in 16 hips vs 142,447 procedures listed for the class).;-At 1st postoperative year: 6.2% (0.0%¿17.4%) vs 2.4% (2.4%¿2.5%) of the class.;-At 2nd postoperative year: 6.2% (0.0%¿17.4%) vs 2.8% (2.7%¿2.9%) of the class.;-At 3rd postoperative year: 6.2% (0.0%¿17.4%) vs 3.0% (2.9%¿3.1%) of the class.;-At 4th postoperative year: 6.2% (0.0%¿17.4%) vs 3.2% (3.1%¿3.3%) of the class.;-At 5th postoperative year: 6.2% (0.0%¿17.4%) vs 3.5% (3.3%¿3.6%) of the class.;-At 7th postoperative year: 6.2% (0.0%¿17.4%) vs 3.9% (3.8%¿4.0%) of the class.;;3.Non-Elective THA after bone fracture(s) (REFECTION Acetabular Component used in 29 hips vs 43,021 procedures listed for the class).;-At 1st postoperative year: 3.4% (0.0%¿9.9%) vs 6.1% (5.8%¿6.3%) of the class.;-At 2nd postoperative year: 7.3% (0.0%¿16.6%) vs 6.6% (6.4%¿6.9%) of the class.;-At 3rd postoperative year: 7.3% (0.0%¿16.6%) vs 7.0% (6.8%¿7.3%) of the class.;-At 4th postoperative year: 7.3% (0.0%¿16.6%) vs 7.3% (7.1%¿7.6%) of the class.;-At 5th postoperative year: 7.3% (0.0%¿16.6%) vs 7.6% (7.4%¿7.9%) of the class.;-At 7th postoperative year: 7.3% (0.0%¿16.6%) vs 8.2% (7.9%¿8.6%) of the class.;-At 9th postoperative year: 7.3% (0.0%¿16.6%) vs 8.8% (8.3%¿9.2%) of the class.;;The two most frequent causes of revision were: infections (17.6%) and other/unknown (50%). Revision due to infection are most likely not due to the implant itself, and rather due to issues with the surgical technique or pre-existing conditions. Wide confidence intervals associated with REFLECTION implants may be affected by the relatively low number of implantations.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem

BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY: 1. PRIMARY TOTAL HIP ARTHROPLASTY R3 ACETABULAR SHELL COMPONENT: IMPLANTED IN A TOTAL OF THIRTY-ONE THOUSAND TWO HUNDRED AND SEVENTY-SEVEN (31,277) HIPS BETWEEN 01-FEB-2013 AND 31-MAR-2025. FROM THESE, ONE THOUSAND ONE HUNDRED AND FIFTY-NINE (1,159) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: TWO HUNDRED EIGHTY-SIX (286) HIPS DUE TO INFECTION, ONE HUNDRED FORTY-FOUR (144) HIPS DUE TO DISLOCATION/INSTABILITY, ONE HUNDRED TWENTY-SIX (126) HIPS DUE TO FRACTURE, TWENTY-SIX (26) HIPS DUE TO MALPOSITION/MALALIGNMENT, ONE HUNDRED THIRTEEN (113) HIPS DUE TO ASEPTIC LOOSENING, TWENTY-SIX (26) HIPS DUE TO WEAR, AND FOUR HUNDRED THIRTY-EIGHT (438) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 1,159 TOTAL REVISION SURGERIES, 955 WERE PREVIOUSLY SUBMITTED TO FDA AND 204 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 ACCESSORY ACETABULAR COMPONENT: IMPLANTED IN A TOTAL OF EIGHTEEN THOUSAND SIX HUNDRED NINETY-THREE (18,693) HIPS BETWEEN 01-FEB-2013 AND 31-MAR-2025. FROM THESE, SIX HUNDRED AND SEVENTY (670) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SEVENTY-EIGHT (78) HIPS DUE TO DISLOCATION/INSTABILITY, ONE HUNDRED AND EIGHTY-TWO (182) HIPS DUE TO INFECTION, SIXTY-FOUR (64) HIPS DUE TO PERIPROSTHETIC FRACTURE, SIXTEEN (16) HIPS DUE TO MALPOSITION/MALALIGNMENT, SIXTY-THREE (63) HIPS DUE TO ASEPTIC LOOSENING, TWENTY-SIX (26) HIPS DUE TO WEAR, TWO HUNDRED FORTY-ONE (241) DUE TO OTHER/UNKNOWN REASONS. OF THE 670 TOTAL REVISION SURGERIES, 564 WERE PREVIOUSLY SUBMITTED TO FDA AND 106 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFECTION ACETABULAR COMPONENT: IMPLANTED IN A TOTAL OF ONE THOUSAND TWO HUNDRED THIRTY-SIX (1,236) HIPS BETWEEN 01-FEB-2013 AND 31-JAN-2024. FROM THESE, THIRTY-FOUR (34) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: SIX (6) HIPS DUE TO INFECTION, TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE, FOUR (4) HIPS DUE TO DISLOCATION/INSTABILITY, FOUR (4) HIPS DUE TO ASEPTIC LOOSENING, ONE (1) HIP DUE TO WEAR AND SEVENTEEN (17) HIPS DUE TO OTHER-UNKNOWN REASONS. OF THE 34 TOTAL REVISION SURGERIES, 31 WERE PREVIOUSLY SUBMITTED TO FDA AND 3 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION TOTAL HIP ARTHROPLASTY: R3 ACETABULAR SHELL COMPONENT: IMPLANTED IN A TOTAL OF SEVEN HUNDRED AND SIX (706) HIPS BETWEEN 01-JUL-2013 AND 31-MAR-2025. OF THESE, NINETY-TWO (92) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: TWENTY-SEVEN (27) HIPS DUE TO INFECTION, FOURTEEN (14) HIPS DUE TO DISLOCATION/INSTABILITY, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE, NINETEEN (19) HIPS DUE TO ASEPTIC LOOSENING, SEVEN (7) HIPS DUE TO WEAR, AND TWENTY-TWO (22) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 92 TOTAL RE-REVISION SURGERIES, 80 WERE PREVIOUSLY SUBMITTED TO FDA AND 12 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 ACCESSORY ACETABULAR COMPONENT: IMPLANTED IN A TOTAL OF FOUR HUNDRED NINETY-FOUR (494) HIPS BETWEEN 01-NOV-2014 AND 31-MAR-2025. FROM THESE, SEVENTY-SIX (76) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWENTY-FIVE (25) HIPS DUE TO INFECTION, FOURTEEN (14) HIPS DUE TO DISLOCATION/INSTABILITY, TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE, FIFTEEN (15) HIPS DUE TO ASEPTIC LOOSENING, FIVE (5) HIPS DUE TO WEAR, FIFTEEN (15) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 76 TOTAL RE-REVISION SURGERIES, 60 WERE PREVIOUSLY SUBMITTED TO FDA AND 16 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. ALTOGETHER, A TOTAL QUANTITY OF 313 REVISIONS AND 28 RE-REVISIONS (341 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2026). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE GERMANY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY: 1. PRIMARY TOTAL HIP ARTHROPLASTY R3 ACETABULAR SHELL COMPONENT: IMPLANTED IN A TOTAL OF THIRTY-ONE THOUSAND TWO HUNDRED AND SEVENTY-SEVEN (31,277) HIPS BETWEEN 01-FEB-2013 AND 31-MAR-2025. FROM THESE, ONE THOUSAND ONE HUNDRED AND FIFTY-NINE (1,159) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: TWO HUNDRED EIGHTY-SIX (286) HIPS DUE TO INFECTION, ONE HUNDRED FORTY-FOUR (144) HIPS DUE TO DISLOCATION/INSTABILITY, ONE HUNDRED TWENTY-SIX (126) HIPS DUE TO FRACTURE, TWENTY-SIX (26) HIPS DUE TO MALPOSITION/MALALIGNMENT, ONE HUNDRED THIRTEEN (113) HIPS DUE TO ASEPTIC LOOSENING, TWENTY-SIX (26) HIPS DUE TO WEAR, AND FOUR HUNDRED THIRTY-EIGHT (438) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 1,159 TOTAL REVISION SURGERIES, 955 WERE PREVIOUSLY SUBMITTED TO FDA AND 204 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 ACCESSORY ACETABULAR COMPONENT: IMPLANTED IN A TOTAL OF EIGHTEEN THOUSAND SIX HUNDRED NINETY-THREE (18,693) HIPS BETWEEN 01-FEB-2013 AND 31-MAR-2025. FROM THESE, SIX HUNDRED AND SEVENTY (670) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SEVENTY-EIGHT (78) HIPS DUE TO DISLOCATION/INSTABILITY, ONE HUNDRED AND EIGHTY-TWO (182) HIPS DUE TO INFECTION, SIXTY-FOUR (64) HIPS DUE TO PERIPROSTHETIC FRACTURE, SIXTEEN (16) HIPS DUE TO MALPOSITION/MALALIGNMENT, SIXTY-THREE (63) HIPS DUE TO ASEPTIC LOOSENING, TWENTY-SIX (26) HIPS DUE TO WEAR, TWO HUNDRED FORTY-ONE (241) DUE TO OTHER/UNKNOWN REASONS. OF THE 670 TOTAL REVISION SURGERIES, 564 WERE PREVIOUSLY SUBMITTED TO FDA AND 106 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFECTION ACETABULAR COMPONENT: IMPLANTED IN A TOTAL OF ONE THOUSAND TWO HUNDRED THIRTY-SIX (1,236) HIPS BETWEEN 01-FEB-2013 AND 31-JAN-2024. FROM THESE, THIRTY-FOUR (34) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: SIX (6) HIPS DUE TO INFECTION, TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE, FOUR (4) HIPS DUE TO DISLOCATION/INSTABILITY, FOUR (4) HIPS DUE TO ASEPTIC LOOSENING, ONE (1) HIP DUE TO WEAR AND SEVENTEEN (17) HIPS DUE TO OTHER-UNKNOWN REASONS. OF THE 34 TOTAL REVISION SURGERIES, 31 WERE PREVIOUSLY SUBMITTED TO FDA AND 3 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION TOTAL HIP ARTHROPLASTY: R3 ACETABULAR SHELL COMPONENT: IMPLANTED IN A TOTAL OF SEVEN HUNDRED AND SIX (706) HIPS BETWEEN 01-JUL-2013 AND 31-MAR-2025. OF THESE, NINETY-TWO (92) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: TWENTY SEVEN (27) HIPS DUE TO INFECTION, FOURTEEN (14) HIPS DUE TO DISLOCATION/INSTABILITY, THREE (3) HIPS DUE TO PERIPROSTHETIC FRACTURE, NINETEEN (19) HIPS DUE TO ASEPTIC LOOSENING, SEVEN (7) HIPS DUE TO WEAR, AND TWENTY TWO (22) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 92 TOTAL RE-REVISION SURGERIES, 80 WERE PREVIOUSLY SUBMITTED TO FDA AND 12 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. R3 ACCESSORY ACETABULAR COMPONENT: IMPLANTED IN A TOTAL OF FOUR HUNDRED NINETY-FOUR (494) HIPS BETWEEN 01-NOV-2014 AND 31-MAR-2025. FROM THESE, SEVENTY-SIX (76) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: TWENTY-FIVE (25) HIPS DUE TO INFECTION, FOURTEEN (14) HIPS DUE TO DISLOCATION/INSTABILITY, TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE, FIFTEEN (15) HIPS DUE TO ASEPTIC LOOSENING, FIVE (5) HIPS DUE TO WEAR, FIFTEEN (15) HIPS DUE TO OTHER/UNKNOWN REASONS. OF THE 76 TOTAL RE-REVISION SURGERIES, 60 WERE PREVIOUSLY SUBMITTED TO FDA AND 16 NEW RE-REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. ALTOGETHER, A TOTAL QUANTITY OF 313 REVISIONS AND 28 RE-REVISIONS (341 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE ENDOPROTHESENREGISTER DEUTSCHLAND (EPRD) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE R3 ACETABULAR SYSTEM AND REFECTION ACETABULAR SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENTS WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. EPRD REPORTS THAT FOR THE R3 ACETABULAR SHELL COMPONENTS, OBSERVING THE CUMULATIVE REVISION RATES IT CAN BE DETERMINED THAT STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE STUDY DEVICE AND THE THR CLASS ARE PRESENT ONLY AT THE 1ST AND 3RD POSTOPERATIVE YEARS, WHERE THE STUDY DEVICE DEMONSTRATES HIGHER REVISION RATES THAN THE CLASS, AS INDICATED BY NON-OVERLAPPING 95% CONFIDENCE INTERVALS. FOR ALL OTHER EVALUATED POSTOPERATIVE PERIODS, THE 95% CONFIDENCE INTERVALS OVERLAP, INDICATING NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE REVISION RATES OF THE STUDY DEVICE AND THE THR CLASS AT THOSE TIME POINTS. FOR THE CUMULATIVE RE-REVISION RATES, IT CAN BE DETERMINED THAT THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE RE-REVISION RATES OF THE STUDY DEVICE AND THE REVISION THR CLASS AT ANY POSTOPERATIVE TIME POINT EVALUATED, AS DETERMINED BY OVERLAPPING 95% CONFIDENCE INTERVALS. FOR THE CUMULATIVE REVISION RATES AND RE-REVISION RATES OF THE R3 ACCESSORY ACETABULAR COMPONENTS, THEY ARE PERFORMING IN LINE WITH THE RESPECTIVE CLASS SUBCATEGORY AT THE AVAILABLE FOLLOW-UP TIME (1-10 YEARS) BASED ON OVERLAPPING OF CONFIDENCE INTERVALS. THE REVISION RATE FOR REFLECTION ACETABULAR COMPONENT WAS EITHER STATISTICALLY SIGNIFICANTLY LOWER, OR NOT STATISTICALLY SIGNIFICANTLY DIFFERENT THAT ALL OTHER THAS AT THE AVAILABLE FOLLOW-UP TIME. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.